Miniaturized Global Coagulation Assay System in Neonatal and Pediatric Settings

Atantares Corporation, Arlington MA

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Abstract

Project Summary Atantares Corp. is seeking funding to develop a standardized foundation of thrombosis evaluation, driven through the principle of unification of standard laboratory and specialized hemostasis testing, inclusive of a diversity of tests such as thromboelastography (TEG), PT/APTT, multiple electrode aggregometer etc., with the potential for iterative advance and multiplexing. Clinical realization of such a platform is far from the mere addition of various tests into a single unit, but transformative, particularly in the pediatric cases where innate diversity in hemorrhagic and thrombotic status is juxtaposed diversity in disease and treatment. Flexible platforms are required. Equally important, sensor miniaturization through our MEMS/microfluidic approach significantly reduces required blood volume (test and dead-space) to perform these various assays, making it ideal for pediatric patients. With deep expertise in MEMS technology, Atantares Corp has designed and is reducing to practice miniaturized and accurate modules of a diversity of hemostasis assays that can be used in isolation, in serial, or in parallelizable fashion at a fraction of the cost and footprint of current stand-alone systems. This technology also synergizes closely with the academic mission of Dr. Kolandaivelu who has examined in detail, the patient specific underpinnings of patient-specific thrombotic events following endovascular manipulations and in an effort to better understand the blood-borne contributors to risk, developed multi-parameter methods of mapping an individual?s hemostatic state in high definition. Availability of a modular tool can interface directly into existing workflows and provider preferences, at the same time, being leveraged to cost-effectively and systematically build out the needed evidence-base for new applications despite diverse pediatric scenarios (innate variability, ECMO, CHD, arrhythmias, hemophilias, coagulopathies, NICU settings, etc.). In the scope of this SBIR program, Atantares Corp. will demonstrate the key advantages of MEMS/microfluid technology in functional global hemostasis assays through two specific aims that seek to 1) Create high accuracy MEMS sensors for functional hemostasis assessment (exemplified herein as a uTEG unit; note, TEG is exemplary of a complex module with growing clinical value); as well as 2) Global assay optimization to maximize signal:noise at minimal test volume.